[Federal Register Volume 70, Number 82 (Friday, April 29, 2005)]
[Proposed Rules]
[Pages 22274-22283]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8574]
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DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade Bureau
27 CFR Parts 4, 5, and 7
[Notice No. 41]
RIN 1513-AB07
Labeling and Advertising of Wines, Distilled Spirits and Malt
Beverages; Request for Public Comment
AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau (TTB) requests
public
[[Page 22275]]
comment on possible changes to the labeling and advertising
requirements of alcohol beverage products regulated by TTB. The agency
has long required certain labeling, such as brand name, class and type,
alcohol content (in the case of wines containing more than 14 percent
alcohol by volume and distilled spirits), net contents, and in recent
years has published updated standards for the use of carbohydrate and
calorie claims. Because of petitions to mandate additional information,
including ingredient, allergen, alcohol, calorie, and carbohydrate
content and requests by some to use labels with at least some of that
additional information on a voluntary basis under existing rules, TTB
believes it is now appropriate to consider revising the alcohol
beverage labeling and advertising regulations, and seeks public comment
on several issues to assist the agency in formulating specific
regulatory proposals.
DATES: We must receive written comments on or before June 28, 2005.
ADDRESSES: You may send comments to any one of the following addresses:
Chief, Regulations and Procedures Division, Alcohol and
Tobacco Tax and Trade Bureau, Attn: Notice No. 41, P.O. Box 14412,
Washington, DC 20044-4412.
202-927-8525 (facsimile).
nprm@ttb.gov (e-mail).
http://www.ttb.gov/alcohol/rules/index.htm (an online
comment form is posted with this notice on our Web site).
http://www.regulations.gov (Federal e-rulemaking portal;
follow instructions for submitting comments).
You may view copies of this advance notice, the petitions, and any
comments we receive on this notice by appointment at the TTB Library,
1310 G Street, NW., Washington, DC 20220. To make an appointment, call
202-927-2400. You may also access copies of the advance notice and
comments online at http://www.ttb.gov/alcohol/rules/index.htm.
See Section VI of this notice for specific instructions and
requirements for submitting comments and for information on how to
request a public hearing.
FOR FURTHER INFORMATION CONTACT: Lisa M. Gesser, Regulations and
Procedures Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box
128, Morganza, MD 20660; (301) 290-1460.
SUPPLEMENTARY INFORMATION:
I. Introduction
TTB is soliciting public comment on a wide range of alcohol
beverage labeling and advertising issues to help the agency determine
what regulatory changes in alcohol beverage labeling and advertising
requirements, if any, TTB should propose in future rulemakings. Because
of increased interest in including nutrition and ingredient information
on alcohol beverage labels, TTB believes it is now appropriate to
consider amending the alcohol beverage labeling and advertising
regulations to provide more specific information to the consumer.
Accordingly, TTB is soliciting public comments on appropriate ways
to use alcohol beverage labels to inform the public about the identity
and quality of the products. In addition to specific questions posed
later in this advance notice, TTB invites responses to the following
general questions:
1. Should TTB seek to require mandatory nutrition labeling (that
is, calories, fat, carbohydrates, and protein) for alcohol beverage
products, or should nutrition information be permitted only on a
voluntary basis?
2. Should TTB seek to require mandatory ingredient labeling (that
is, a list of all ingredients used to make the product, including
processing aids) for alcohol beverage products, or should ingredient
labeling be permitted only on a voluntary basis?
3. What areas need further research and evaluation before TTB can
reach decisions on whether and how changes can be made?
4. Are there modifications TTB can make to current requirements
regarding alcohol beverage labels to help consumers better understand
and benefit from the information on the label?
5. Should TTB harmonize its alcohol beverage labeling regulatory
requirements with those of other major producing nations, such as the
Member States of the European Union, Australia, and Canada, and with
regulatory schemes of other Federal agencies, such as the Food and Drug
Administration (FDA)? If so, how would that be best done?
6. Are consumers likely to derive benefits from more specific
information on alcohol beverage labels, and, if so, are those benefits
sufficient to warrant the economic costs associated with such
revisions?
7. What should be the agency's priorities in deciding which changes
to make on alcohol beverage labels, that is, which changes are most
important and which are least important?
8. Should any new labeling requirements apply equally to
advertisements?
II. TTB's Authority To Prescribe Alcohol Beverage Labeling and
Advertising Regulations
Federal Alcohol Administration Act
Sections 105(e) and 105(f) of the Federal Alcohol Administration
Act (FAA Act), codified in the United States Code at 27 U.S.C. 205(e)
and 205(f), set forth standards for regulation of the labeling and
advertising of distilled spirits, wine (at least 7 percent alcohol by
volume), and malt beverages, generally referred to as alcohol beverage
products throughout this document. These sections give the Secretary of
the Treasury the authority to issue regulations to prevent deception of
the consumer, to provide the consumer with ``adequate information'' as
to the identity and quality of the product, and to prohibit false or
misleading statements. Additionally, these FAA Act provisions give the
Secretary the authority to prohibit, irrespective of falsity,
statements relating to age, manufacturing processes, analyses,
guarantees, and scientific or irrelevant matters which are likely to
mislead the consumer. In the case of malt beverages, the labeling and
advertising provisions of the FAA Act apply only if the laws of the
State into which the malt beverages are to be shipped impose similar
requirements. TTB is responsible for the administration of the FAA Act
and the regulations promulgated under it.
TTB's Implementing Regulations
Subject to certain jurisdictional limitations, the FAA Act requires
that alcohol beverage labels and advertisements be in conformity with
the regulations prescribed under it. The basic FAA Act implementing
regulations, which appear as parts 4, 5, and 7 in title 27 of the Code
of Federal Regulations (27 CFR parts 4, 5, and 7), specifically state
what mandatory information must appear, and what is prohibited from
appearing, on labels and in advertisements. Most of the mandatory
labeling information requirements for alcohol beverages flow directly
from the purpose stated in the statute, that is, to ``provide the
consumer with adequate information as to the identity and quality of
the products, the alcoholic content thereof * * * the net contents of
the package, and the manufacturer or bottler or importer of the
product.'' See 27 U.S.C. 205(e). The current specific requirements may
be summarized as follows: brand name, product identity, the name and
address of the bottler, packer, or importer, the net contents and
alcohol content (see below) of the
[[Page 22276]]
product, and the presence of sulfites, FD&C Yellow No. 5, and in the
case of malt beverages, aspartame. (The health warning statement is
required pursuant to a different provision of the FAA Act, the
Alcoholic Beverage Labeling Act of 1988, codified at 27 U.S.C. 213-219
and 219a.)
In the case of alcohol content, it should be noted that alcohol
content statements are not mandatory for all alcohol beverages falling
within TTB's jurisdiction. The FAA Act provides that in the case of
wines, statements of alcohol content shall be required only for wines
containing more than 14 percent of alcohol by volume. See 27 U.S.C.
205(e). The implementing regulations provide that wines having an
alcohol content of 14 percent alcohol by volume or less may bear on
their labels either an alcohol content statement or the type
designation ``table'' wine or ``light'' wine. See 27 CFR 4.36(a).
In the case of malt beverages, the FAA Act as enacted specifically
prohibited the placement of alcohol content statements on malt beverage
labels, unless required by State law. This provision of the law was
found to be unconstitutional by the Supreme Court in Rubin v. Coors
Brewing Co., 514 U.S. 476 (1995). Accordingly, the regulations at 27
CFR 7.71 now allow the placement of optional alcohol content statements
on malt beverage labels, unless prohibited by State law. The
regulations do not currently require an alcohol content statement on
malt beverage labels; however, effective January 3, 2006, certain
flavored malt beverages will be required to bear an alcohol content
statement on the brand label (see TTB T.D.-21, 70 FR 194).
The implementing regulations establish the ``identity'' of alcohol
beverage products by defining certain classes and types for wines and
distilled spirits. With regard to malt beverages, statements of class
and type must conform to the designation of the product as known to the
trade. The class and type regulations were promulgated shortly after
the enactment of the FAA Act in 1935, and with relatively few
exceptions, these standards have remained unchanged since then.
The regulations also prohibit, irrespective of falsity, statements
that directly, or by ambiguity, omission or inference, or by the
addition of irrelevant, scientific or technical matter, tend to create
a misleading impression. Additionally, the regulations prohibit the use
of any health-related statements in the labeling and advertising of
alcohol beverages, if such statements are untrue in any particular or
tend to create a misleading impression. TTB evaluates such statements
on a case-by-case basis, and may require a disclaimer or some other
qualifying statement to dispel any misleading impression created by the
health-related statement. Statements concerning calorie, carbohydrate,
protein, and fat content are not considered health-related statements
within the meaning of the TTB regulations.
In order to prevent the sale or shipment of improperly labeled
alcohol beverages in interstate or foreign commerce, the FAA Act
requires industry members to obtain a certificate of label approval
prior to the bottling of, or removal from customs custody in bottles
of, distilled spirits, wines, or malt beverages. The regulations do not
require a certificate of label approval for products exported in bond.
If an industry member can establish that a domestic wine or distilled
spirits product is not to be sold, offered for sale, shipped or
delivered for shipment, or otherwise introduced, in interstate or
foreign commerce, a certificate of exemption is issued.
Industry members are not required to submit advertisements to TTB
for review prior to use. However, TTB encourages industry members to
voluntarily submit advertising materials for pre-clearance by the
Bureau. In addition, TTB monitors advertisements that are already in
the marketplace as part of its comprehensive compliance program to
protect the consumer and encourage industry compliance (see Industry
Circular 2004-6, dated November 19, 2004).
TTB and its predecessor agencies have traditionally utilized
rulings for expressing interpretations of these regulations. The
questions now before the Bureau require public rulemaking to resolve
because some of the changes on which we are soliciting comments go
beyond the mere interpretation of existing regulations.
III. Alcohol Beverage Ingredient Labeling History
In the case of ingredient disclosure, the Department of the
Treasury has considered this issue on a number of occasions dating back
to 1972 when the Center for Science in the Public Interest (CSPI), a
consumer health organization, petitioned TTB's predecessor, the Bureau
of Alcohol, Tobacco and Firearms (ATF), to require ingredient labeling.
As a result of that petition, ATF published in the Federal Register
Docket Nos. 74-17720, 75-3719, and 75-3720 (39 FR 27812, 40 FR 6354,
and 40 FR 6349) proposing amendments to 27 CFR parts 4, 5, and 7
regarding ingredient labeling of alcohol beverages. The agency held
three public hearings over the course of six days and received in
excess of 1,000 written comments on the matter. After considering all
representations, on November 11, 1975, ATF published Notice No. 285 in
the Federal Register (40 FR 52613) withdrawing the ingredient labeling
proposals, stating five reasons: (1) The cost of ingredient labeling to
the industry, and ultimately to the consumer, would be excessive in
relation to the benefit received; (2) the content of alcohol beverages
is extensively regulated; (3) the uniqueness of manufacturing processes
of alcohol beverages is such that it makes labeling of their
ingredients of little value, and in certain cases, even misleading
because ingredients that are used to make the product are not
necessarily present in the finished product; (4) ingredient labeling
requirements would interfere with international trade negotiations; and
(5) ingredient labeling is supported by only a small segment of the
public.
Subsequently, on February 2, 1979, ATF published Notice No. 834 in
the Federal Register (44 FR 6740) proposing requirements for ingredient
labeling of alcohol beverages. During the comment period, ATF received
over 1,800 comments from consumers, special interest groups, industry
members, doctors, government agencies and members of Congress.
Thereafter, on June 13, 1980, ATF published in the Federal Register (45
FR 40538) a final rule, T.D. ATF-66, which required ingredient
disclosure on all alcohol beverages sold in the United States. The
final rule included an exception to the requirement. Under the
exception, an ingredient list would not have to appear on the label
when the producer, bottler, or importer:
(1) Elects to make an ingredient list available upon request;
(2) Places a statement on the front label or on a separate strip
label notifying the consumer of the availability of an ingredient list
and provides the name and, somewhere on the label, a full mailing
address in the United States where such an ingredient list can be
obtained upon request; and
(3) Does not place a statement on the label that could be
misconstrued to be an ingredient list (for example, a partial
ingredient list).
ATF stated that this exception would give the industry maximum
flexibility to provide ingredient information at a minimum cost. At the
same time, it would provide consumers who have the need or desire to
avoid various ingredients a means to do so, thus
[[Page 22277]]
meeting the objective of Notice No. 834. Also, because of specific
health concerns, T.D. ATF-66 mandated the label disclosure of FD&C
Yellow No. 5 whenever it is used in a product. The new labeling
regulations were to take effect on January 1, 1983.
On February 17, 1981, President Reagan issued Executive Order
12291, which was published in the Federal Register on February 19, 1981
(46 FR 13193). Executive Order 12291 required each Federal agency to
establish a management system that would improve the quality and lessen
the burden of Federal regulation. Executive Order 12291 required
agencies, within their legal authority, to establish regulatory goals,
to set regulatory priorities, to review existing regulations, and to
implement new regulations with the aim of maximizing the benefits to
society while at the same time imposing the least burden to achieve
those benefits.
As a result of ATF's review of existing regulations called for by
Executive Order 12291, ATF concluded that T.D. ATF-66 was not in accord
with the President's mandate. Therefore, on May 4, 1981, ATF published
Notice No. 372 in the Federal Register (46 FR 24962) proposing to
rescind the ingredient labeling amendments before they became
mandatory.
ATF received a total of 8,068 comments containing 23,352 individual
signatures. Of the comments received, 4,909 comments representing
17,138 individuals supported the proposal to rescind the ingredient
labeling regulations and 3,159 comments, representing 6,214
individuals, opposed the rescission. In T.D. ATF-94, published in the
Federal Register (46 FR 55093) on November 6, 1981, ATF rescinded the
ingredient labeling regulations, concluding that the costs were
disproportionate to the benefits that would be gained from the
additional label information. ATF further concluded that ingredient
labeling would not result in an appreciable benefit to consumers when
compared to the existing label information requirements and standards
of identity. ATF noted in this regard that under the FAA Act
regulations, a standard of identity generally identifies the basic
agricultural ingredient and sets forth standards for production and
alcohol content.
On February 8, 1983, CSPI and two individual consumers filed an
action in the United States District Court for the District of Columbia
contesting the rescission. See Center for Science in the Public
Interest v. Department of the Treasury, 573 F. Supp. 1168 (D.D.C.
1983), appeal dismissed, Center for Science in the Public Interest v.
Regan, 727 F.2d 1161 (D.C. Cir. 1984). As a result of the suit, the
district court held invalid and set aside Treasury's decision to
rescind T.D. ATF-66 for failure to comply with the Administrative
Procedure Act and for violating its statutory mandate under the FAA
Act. In essence, the court found that ATF failed to adequately explain
the reversal of the prior rule and placed undue weight on cost factors.
The court then ordered ATF to announce a new date, not later than one
year from the date of the order, to put the regulations of T.D. ATF-66
into effect. Accordingly, in a notice published in the Federal Register
(48 FR 10309) on March 11, 1983, ATF reinstated the ingredient labeling
regulations as originally promulgated in T.D. ATF-66 and mandated
compliance by February 8, 1984.
Subsequently, ATF decided to reexamine the ingredient disclosure
issue. On June 17, 1983, ATF published Notice No. 469 in the Federal
Register (48 FR 27782), proposing to reconsider prior decisions
concerning ingredient disclosure on labels of alcohol beverages and
again proposing to rescind TD ATF-66.
During the comment period, a total of 1,840 comments containing
1,897 signatures were received. Of the total number of comments
received, 1,538 supported the proposal to rescind the ingredient
labeling regulations. Of these comments, 413 were from American alcohol
beverage industry members or related industry members, 64 were from
foreign industry members, four were from foreign governments, one was
from a Federal agency, and 1,056 were from individuals. A total of 290
comments, representing 303 individuals, were received opposing the
rescission of the ingredient labeling regulations.
After considering all of the comments, ATF published T.D. ATF-150
in the Federal Register (48 FR 45549) on October 6, 1983. This final
rule rescinded the T.D. ATF-66 ingredient disclosure regulations
published in 1980 but required the labeling of FD&C Yellow No. 5 by
October 6, 1984. ATF determined that there was no clear evidence that
any other ingredient posed a special health problem. ATF also concluded
that there was no overwhelming desire on the part of consumers for
comprehensive ingredient labeling and questioned its usefulness even if
it were required. ATF further explained that substantial transformation
during the production process means that there is only a strained
relationship between the initial ingredients and the contents of the
final product.
CSPI and others brought suit against the Department of the Treasury
in the United States District Court for the District of Columbia, again
challenging the rescission of T.D. ATF-66. See Center for Science in
the Public Interest v. Department of the Treasury, Civil Action No. 84-
2079, 1985 U.S. Dist. LEXIS 14329 (D.D.C. October 30, 1985). The
plaintiffs challenged T.D. ATF-150, contending primarily that ATF's
rescission violated the FAA Act and was arbitrary and capricious and an
abuse of discretion in violation of the Administrative Procedure Act.
The district court granted summary judgment to the plaintiffs and
ordered the final rule contained in T.D. ATF-150 vacated.
The Government appealed the district court's decision and on August
5, 1986, the United States Court of Appeals for the D.C. Circuit
reversed the decision, affirming ATF's rescission of T.D. ATF-66. See
Center for Science in the Public Interest v. Department of the
Treasury, 797 F.2d 995 (D.C. Cir. 1986). The court concluded that ATF's
rationale for rescinding the labeling rule, that the ingredient
disclosure rule would not achieve its intended purpose of providing
consumers with information upon which to make an informed choice, was
reasonably sufficient to support its decision. In particular, the court
upheld ATF's conclusion that the record failed to establish that
ingredient disclosure would provide useful information as to the actual
contents of the alcohol beverage. The court noted that there was ``more
than enough evidence in the record to support the agency's conclusion
that, in many cases, both basic ingredients and additives will be
substantially transformed by distillation and fermentation.'' See 797
F.2d at 1000. Thus, the ingredient labeling rules were rescinded in
accordance with T.D. ATF-150.
The ingredient labeling issue was reopened on December 16, 2003,
when CSPI, together with the National Consumers League and other
organizations and individuals, forwarded a petition to TTB requesting
changes to the labeling regulations in 27 CFR parts 4, 5 and 7. This
petition is discussed in further detail in Section V of this notice.
IV. Alcohol Beverage Nutrition Labeling History
On August 10, 1993, in response to a petition submitted by a law
firm on behalf of an unnamed client, ATF published an advance notice of
proposed rulemaking (ANPRM) in the
[[Page 22278]]
Federal Register soliciting comments from the public on whether the
regulations should be amended to require nutrition labeling for alcohol
beverages. See Notice No. 776, 58 FR 42517. The petitioner's stated
purpose was to bring the nutrition labeling requirements for alcohol
beverages in line with the requirements for food and beverage products
regulated by FDA.
In response to the advance notice, ATF received 55 comments. Of
these comments, 41 commenters opposed nutrition labeling (including the
Wine Institute, the Beer Institute, CSPI, and the Delegation of the
Commission of the European Communities). Seven commenters supported
mandatory nutrition labeling (including Seagram's, Brown-Forman, the
American Association of Diabetes Educators, and the petitioner). Two
commenters supported voluntary nutrition labeling. One commenter
supported mandatory nutrition labeling only for ``light,'' reduced
alcohol, and non-alcoholic beverages (for example, near beer).
Based on the comments received in response to the ANPRM, ATF
concluded that there was neither significant consumer interest in
nutrition information for alcohol beverages nor any convincing evidence
that nutrition labeling would provide substantial useful information to
consumers. Consequently, ATF denied the petition and terminated the
rulemaking on this issue.
Presently, TTB requires a Statement of Average Analysis, in effect
a nutrition statement, on all alcohol beverage product labels that bear
calorie or carbohydrate claims. In addition, if an advertisement bears
a carbohydrate or calorie claim (other then the term ``lite'' or
``light'' in the brand name) the advertisement must also bear a
Statement of Average Analysis. These requirements are explained in more
detail in Section V of this notice.
V. Major Issues Under Consideration
The specific issues and questions on which TTB is seeking public
comment are discussed in the remainder of this notice.
A. Calorie and Carbohydrate Claims
In 1976, ATF issued a ruling that allowed the use of caloric and
carbohydrate references as part of a statement of average analysis on
malt beverage labels. See ATF Rul. 76-1, 1976 ATF C.B. 82. In
subsequent rulings, ATF modified certain requirements with respect to
malt beverage labeling statements, and announced its intention to
engage in rulemaking on the use of the terms ``light'' and ``lite'' on
malt beverage labels. See ATF Rul. 79-17, ATF Q.B. 1979-3, 3, and ATF
Rul. 80-3, A.T.F.Q.B. 1980-2, 13.
In the 1980s, ATF published in the Federal Register three notices
of proposed rulemaking, soliciting comments on substantive standards
for use of the terms ``light'' and ``lite'' on alcohol beverage labels.
In Notice No. 362 (45 FR 83530, December 19, 1980), ATF proposed a rule
that would have required, among other things, that whenever references
to calorie or carbohydrate content were made on wine, distilled
spirits, or malt beverage labels, a statement of average analysis must
also appear on the label. However, no statement of average analysis
would be required if the word ``lite'' were used in accordance with
current regulations (such as part of the designation ``light wine''),
or if it was used to describe a characteristic of the product, such as
``light taste'' or ``light flavor.''
After the issuance of Notice No. 362, CSPI petitioned the Bureau
for an amendment that would require mandatory caloric content labeling
for all alcohol beverages and establish a maximum calorie limit for
alcohol beverages designated as ``light,'' ``lite,'' or low in
calories. In Notice No. 600 (51 FR 28836, August 12, 1986), ATF
announced its conclusion that mandatory caloric labeling for all
alcohol beverages was unnecessary, and also rejected CSPI's suggestion
to establish upper limits on low-calorie alcohol beverages. It again
solicited comments on requiring a statement of average analysis on
labels where the terms ``light'' or ``lite'' were used to denote low
calories, and proposed that the calorie statement must appear on the
brand label, while the remainder of the statement of average analysis
could appear on any label.
In Notice No. 659 (53 FR 22678, June 17, 1988), ATF proposed a
substantive standard for the use of ``light'' or ``lite'' as part of
the brand or product name of a wine, distilled spirits, or malt
beverage product. ATF solicited comments on two alternatives. The first
would restrict the terms to products that contain at least 20 percent
fewer calories than the producer's regular product, or if the producer
did not make a regular product, 20 percent fewer calories than a
competitor's same or similar regular product. The second alternative
would require a statement on the label of the number of calories in the
light product and in a ``regular'' product made by the producer or (if
the producer does not make a ``regular'' product), a competitor.
After reviewing the comments on these various proposals, the Bureau
decided not to issue a regulation governing the use of the terms
``light'' and ``lite'' on alcohol beverage labels.
Within the past few years, the industry expressed greater interest
in the use of carbohydrate claims on alcohol beverage labels.
Furthermore, TTB received inquiries from producers of wines and
distilled spirits who wanted to know whether ATF Rul. 80-3 applied to
their products in addition to malt beverages. Accordingly, on April 7,
2004, TTB issued Ruling 2004-1 to provide guidance to industry about
the use of calorie and carbohydrate claims in the advertising and
labeling of alcohol beverages.
The ruling allows for the use of truthful and specific statements
about carbohydrate and calorie content while prohibiting statements
that are false or misleading or that imply that consumption of low-
carbohydrate alcohol beverages may play a healthy role in a weight
maintenance or weight reduction plan. TTB believes that such claims are
misleading in that they provide incomplete information about the health
effects of alcohol consumption.
The ruling held that calorie and carbohydrate representations in
the labeling and advertising of alcohol beverages are considered to be
misleading unless they provide with such representations a ``statement
of average analysis.'' A statement of average analysis must list the
serving size as well as the quantity of each of the following contained
in a single serving size:
Calories;
Carbohydrates (in grams);
Protein (in grams); and
Fat (in grams).
As part of the ruling, TTB issued interim standards for the use of
terms such as ``low carbohydrate,'' ``reduced carbohydrate,'' and
``lower carbohydrate.'' The ruling did not, however, provide specific
standards for the use of terms such as ``low calorie,'' ``reduced
calorie,'' or ``lower calorie.'' TTB Ruling 2004-1 allows for the use
of:
``Low carbohydrate'' (or ``low carb'') on labels and in
advertisements where: (1) a statement of average analysis is present;
and (2) the standard serving size for the product (12 fl. oz. for malt
beverages, 5 fl. oz. for wines, and 1.5 fl. oz. for distilled spirits)
contains no more than 7 grams of carbohydrates.
``Reduced carbohydrate'' and ``lower carbohydrate'' on a
label or in an advertisement that bears a statement of average
analysis, as long as the term is
[[Page 22279]]
used as part of a statement that specifies the number of carbohydrates
per serving size and compares that number with the number of
carbohydrates in another specified product made by that producer; for
example, ``Reduced carbohydrate--10 grams of carbohydrates per 12 fl.
oz. serving--40 percent fewer than in our [Brand name] malt beverage''
or ``Lower carbohydrate--15 grams of carbohydrates per 5 fl. oz.--less
than half the carbohydrates in our [brand name] wine.''
The ruling also held that, pending rulemaking on this issue, the
terms ``effective carbohydrates'' and ``net carbohydrates'' are
considered misleading and that their use on labels and in
advertisements is prohibited.
TTB recognizes that the best way to develop standards for the use
of terms such as ``low carbohydrate'' and ``low calorie'' is through
the public notice and comment rulemaking process. Moreover, because TTB
and FDA both have jurisdiction over alcohol beverages under their
respective statutory mandates, TTB would prefer to have the benefit of
FDA's decision-making process before setting a final ``low
carbohydrate'' standard for alcohol beverage products that do not fall
within FDA's exclusive jurisdiction. FDA has received several
rulemaking petitions to set a standard for the use of the term ``low
carbohydrate'' on food and beverage products they regulate, but has not
yet set a standard.
We would also like to solicit comments on whether we should set
additional substantive standards for the use of calorie claims in the
labeling and advertising of alcohol beverages. FDA has set standards
for the use of calorie claims (including ``calorie-free'', ``low-
calorie,'' ``reduced calorie,'' and ``light'' or ``lite'') on food and
beverage products they regulate. See 21 CFR 101.56 and 101.60(b).
To assist TTB in deciding whether to formulate specific regulatory
proposals, we are soliciting comments from consumers, consumer and
other interest groups, trade associations, and industry members on the
following specific questions. We also are interested in receiving any
additional information that a comment submitter believes is relevant to
the issue of carbohydrate and calorie claims:
1. Should TTB promulgate regulations that define ``low
carbohydrate'' for alcohol beverage products as containing no more than
7 grams of carbohydrates per standard serving size, as specified in
Ruling 2004-1? Why or why not?
2. Should TTB continue to prohibit use of the terms ``effective
carbohydrates'' and ``net carbohydrates'' on labels and in
advertisements? Why or why not?
3. Should TTB wait for the conclusion of FDA's regulatory decision-
making process for the use of the term ``low carbohydrate'' for food
and beverage products FDA regulates before issuing regulations on a low
carbohydrate standard for alcohol beverage products?
4. How should TTB define the terms ``low calorie'' and ``reduced
calorie'' for alcohol beverage products? Should we propose standards
for these claims consistent with FDA's standards? Should we develop our
own alternate set of standards and, if so, what should they be?
5. Should TTB establish regulations for the use of the terms
``light'' and ``lite'' on alcohol beverage labels? If so, should we
propose standards for these claims consistent with FDA's standards? How
would these standards apply to products for which the term ``light'' is
part of the standard of identity (such as ``light whisky'' or ``light
wine'')?
B. Petition for ``Alcohol Facts'' Label and Ingredient Labeling
On December 16, 2003, CSPI, together with the National Consumers
League, 67 other organizations, and eight individuals, forwarded a
petition to TTB requesting changes to the labeling regulations in 27
CFR parts 4, 5, and 7. After receipt of the CSPI petition, additional
individuals wrote to TTB requesting the addition of their names to the
petition. This petition requests issuance of a final rule amending
parts 4, 5, and 7 to require that labels of all alcohol beverages
regulated by TTB include the following information in a standardized
format:
The beverage's alcohol content expressed as a percentage
of volume;
The serving size;
The amount of alcohol in fluid ounces per serving;
The number of calories per serving;
The ingredients (including additives) from which the
beverage is made;
The number of standard drinks per container; and
The U.S. Dietary Guidelines advice on moderate drinking
for men and women.
The petitioners propose that all alcohol beverage containers bear
this information on an ``Alcohol Facts'' label and provide the
following as an example for a 750 milliliter bottle of wine:
[GRAPHIC] [TIFF OMITTED] TP29AP05.090
The petition asks that the words ``Alcohol Facts'' be immediately
followed by a declaration of the number of standard drinks (servings)
per container. The petitioners ask that, consistent with the U.S.
Dietary Guidelines, a serving should be defined as 12 ounces of beer, 5
ounces of wine, and 1.5 ounces of 80-proof distilled spirits. The
petitioners further recommend that for alcohol beverages not fitting
into one of those standard categories, a serving should be defined as
an amount of fluid containing approximately 0.5 ounces of ethyl
alcohol. The petitioners recommend that a consistent graphic symbol
(for example, a beer mug, wine glass, or shot glass) should appear
first, followed by the number of drinks in the container (for example,
``Contains 5 Servings'').
[[Page 22280]]
The petition proposes requiring this information on labels of all malt
beverages, wines, and distilled spirits products regulated by TTB that
contain more than \1/2\ of one percent alcohol by volume. The graphics
and type size for the ``Alcohol Facts'' label should follow the
Nutrition Labeling Education Act (NLEA) standards as set out in 21 CFR
101.9(d), the petitioners suggest. Further, the petitioners state that
ingredient information should appear on the label immediately below,
but segregated from, the ``Alcohol Facts'' box.
To assist TTB in deciding whether to propose specific regulatory
changes in response to the above petition, we are requesting
information from consumers, consumer and other interest groups, trade
associations, and industry members on the desirability and feasibility
of alcohol facts, including ingredient, labeling for alcohol beverages.
Although TTB is soliciting comments on the following specific
questions, the Bureau is also requesting any other relevant information
on the subject.
1. Should alcohol beverage containers bear an Alcohol Facts label
similar to the one presented in the CSPI petition? Why or why not?
2. Should such a label include an ingredient list as suggested in
the CSPI petition?
3. Should the label be voluntary or mandatory?
4. If mandatory, should there be any exemptions from the alcohol
facts and ingredient labels, such as for small businesses or for small
containers?
5. Should current alcohol content statement labeling requirements
be expanded to cover wines with an alcohol content of 14 percent
alcohol by volume or less and malt beverages?
6. What would be the costs associated with mandatory alcohol facts
and ingredient labeling to the industry and, ultimately, the consumer?
7. How might consumers benefit from such a label?
8. As a consumer, how much extra would you be willing to pay for
alcohol facts and ingredient labeling information?
9. Are there alternatives to mandatory alcohol facts and ingredient
labeling for alcohol beverages? For example, if a label lists a Web
site or telephone number where a consumer could obtain such information
about the product, would this be sufficient?
C. Allergen Labeling
On April 10, 2004, Christine A. Rogers, PhD., a senior research
scientist in the Exposure, Epidemiology and Risk Program at the Harvard
School of Public Health, petitioned TTB to change the regulations to
require labeling on alcohol products to list all ingredients and
substances used in processing. Dr. Rogers, who is allergic to egg
protein, is particularly concerned with alcohol beverage products that
contain potentially allergenic substances (wheat, milk, and egg or nut
proteins).
On August 2, 2004, the President signed the Food Allergen Labeling
and Consumer Protection Act of 2004 (FALCP Act, Title II of Public Law
108-282). The FALCP Act amends section 403 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343) to require food and beverage products
that contain an ingredient that bears or contains a major food allergen
to include this information on its label. The FALCP Act's definition of
``major food allergens'' includes milk, eggs, fish, Crustacean
shellfish, tree nuts, peanuts, wheat, and soybeans (as well as most
proteins derived from these foods). The FALCP Act requires that
products containing these ingredients be labeled using plain, common
language; for example, instead of merely listing ``semolina,'' the
label must list ``wheat'', instead of merely listing ``sodium casein,''
the label must list ``milk.'' The FALCP Act allows for several options
for the labeling of allergens in a food or beverage product:
The common name of the allergen can be labeled within
parentheses in the ingredient list, for example: ``Ingredients: Water,
wheat, whey (milk), albumen (eggs), and peanuts''. The label can list
the allergen in summary form after or adjacent to an ingredient list,
for example: ``Ingredients: Water, sugar, whey, and albumen. Allergens:
Milk and egg''.
The House of Representatives Committee Report accompanying the
legislation indicates that TTB is to work with FDA to promulgate
appropriate allergen labeling regulations for alcohol beverages (H.R.
Rep. No. 608, 108th Cong., 2d Sess., at 3 (2004)).
In response to this Congressional instruction and the petition
received from Dr. Rogers, TTB has been meeting with FDA and is
considering rulemaking to require allergen labeling for alcohol
beverages. To assist TTB in determining appropriate allergen labeling
requirements for alcohol beverages, we are requesting information from
consumers, consumer and other interest groups, trade associations, and
industry. Although TTB is soliciting comments on the following specific
questions, the Bureau is also requesting any other relevant information
on the subject.
1. Should TTB require allergen labeling on alcohol beverage
containers to be part of or adjacent to a larger list of all
ingredients found in the product, similar to the requirements of the
Food Allergen Labeling and Consumer Protection Act of 2004? Why or why
not?
2. If the product name appearing on the label of an alcohol
beverage container indicates that an allergen is present in the
product, is it helpful to the consumer to have the allergen labeled
again in a standardized allergen statement elsewhere on the container?
To illustrate: If a product is called ``Wheat Beer,'' should it also
have a label elsewhere on the container that reads: ``Allergens:
wheat''? Why or why not?
3. TTB's current regulations allow certain allergens such as milk,
albumen (egg), isinglass (a protein from fish bladders), and soy flour
to be used as fining, processing, and filtering agents in the
production of alcohol beverages. While fining, processing, and
filtering agents are not primary ingredients in an alcohol beverage
product, low levels of an agent may remain in the final product after
production. When an allergen is used as a fining, processing, or
filtering agent to produce an alcohol beverage, should TTB require that
the product be labeled ``Processed with [a specific allergen]'' or
``May contain [a specific allergen]''? Why or why not?
4. Should allergenic fining, processing, and filtering agents be
labeled in the exact same fashion as all other allergen ingredients?
Why or why not?
5. Testing methods for detecting allergens in food and beverage
products typically can only detect an allergen if it is present at or
above a certain minimum value. In light of that fact, would it be
helpful to consumers for TTB to require an allergenic fining,
processing, or filtering agent to be labeled regardless of whether a
detection test shows that the allergen is or is not present in the
final product? Why or why not?
6. What is the lowest amount of an offending food allergen (or
minimum threshold level) in an alcohol beverage product necessary to
provide a mild, yet perceptible adverse allergic reaction in consumers
with the most sensitive food allergies?
7. Is it possible to define a minimum threshold level for each
major food allergen? If so, what are the minimum threshold levels for
each major food allergen?
8. If FDA and/or the scientific community establish conclusively a
minimum threshold level for a
[[Page 22281]]
particular allergen, should TTB exempt from any allergen labeling
requirements products containing the allergen proteins, but at a level
below the established minimum threshold level? Why or why not?
9. What would be the costs associated with mandatory allergen
labeling to the industry and, ultimately, the consumer?
10. How might consumers benefit from allergen labeling?
D. Requests for Voluntary ``Serving Facts'' Labeling
Following receipt of the petitions discussed above, TTB received
inquires from industry members who would like to begin voluntarily
providing on their labels certain facts about a serving of their
product.
Because of the immediate interest in labeling products in this
fashion, and in light of the length of time needed to conclude public
notice and comment rulemaking procedures, TTB concluded that there was
a need for interim guidance to the industry on what type of ``serving
facts'' information we would allow on alcohol beverage labels and in
advertisements, and in what format TTB would accept this information.
Accordingly, in July and then again in September of 2004, TTB
posted on its Web site, http://www.ttb.gov, a summary of specifications
for a planned ruling concerning the manner in which alcohol beverage
labels and advertising may permissibly reflect information about a
single serving in a ``Serving Facts'' panel, consistent with the
statutory and regulatory standards administered by TTB. The Bureau
sought input from interested parties, including the alcohol beverage
industry, consumers, and consumer interest groups, about what
information should be permitted on such a panel and in what format the
voluntary ``Serving Facts'' panel should be presented.
TTB solicited comments on a variety of options. We asked for
comments on an optional ``Serving Facts'' panel that would include the
serving size in fluid ounces based on what was previously specified in
TTB Ruling 2004-1, the amount of servings per container, and for each
serving the following information:
Fluid ounces of alcohol (ethyl-alcohol) (to the nearest
tenth of an ounce);
Calories;
Fat (in grams);
Carbohydrates (in grams); and
Protein (in grams).
We also solicited comments on a definition of a ``standard drink''
(defined as 0.6 fluid ounces of alcohol) and the number of standard
drinks in a serving. Finally, we solicited comments on the optional use
of three icons similar to the ones at the bottom of the label presented
below:
[GRAPHIC] [TIFF OMITTED] TP29AP05.091
In the second posting on our Web site, TTB solicited comments on an
alternative label approach that omitted the icons and standard drink
references. An example of this approach is as follows:
[[Page 22282]]
[GRAPHIC] [TIFF OMITTED] TP29AP05.092
As a result of the two white papers, TTB received several comments
concerning a voluntary serving facts panel. The comments reflected
strong and varying opinions. A significant proportion of the comment
submitters felt that the issue should be addressed in public notice and
comment rulemaking rather than in a TTB ruling. Furthermore, many
commenters believed that certain elements of the voluntary serving
facts panel would tend to confuse or mislead consumers about the
product.
In response to the issues raised by the commenters, on December 28,
2004, TTB issued a press release indicating that we would address these
issues in an advance notice of proposed rulemaking. Pending the
completion of rulemaking proceedings, TTB does not intend to issue
certificates of label approval bearing the optional ``Serving Facts''
panel. We believe it is important to have the benefit of public
comments on these issues before making a decision as to whether the new
elements in the panel might tend to mislead consumers. We will, of
course, continue to allow the use of statements of average analysis on
alcohol beverage labels.
Accordingly, TTB is requesting comments from consumers, consumer
and other interest groups, trade associations, and industry members on
the desirability and feasibility of adopting serving facts labeling for
alcohol beverages. Although TTB is soliciting comments on the following
specific questions, the Bureau is also requesting any other relevant
information on the subject.
1. Should alcohol beverage containers bear a Serving Facts label
similar to the one presented in this section? Why or why not?
2. Should such a label include a definition of a ``standard drink''
and if so, how should a ``standard drink'' be defined?
3. Should such a label include graphic icons similar to, but not
necessarily limited to, the one presented in this section? Why or why
not?
4. Should the label be voluntary or mandatory?
5. If mandatory, should there be any exemptions from the serving
facts label, such as for small businesses or for small containers?
6. If not mandatory for all alcohol beverage products, should the
Serving Facts label be required at least on alcohol beverages that make
certain calorie or carbohydrate claims?
7. What would be the costs associated with mandatory serving facts
labeling to the industry and, ultimately, the consumer?
8. How might consumers benefit from such a label?
9. As a consumer, how much extra would you be willing to pay for
serving facts labeling information?
10. Are there alternatives to mandatory serving facts labeling for
alcohol beverages? For example, if a label lists a Web site or
telephone number where a consumer could obtain such information about
the product, would this be sufficient?
11. Should TTB allow a further breakdown of nutrients (for example,
trans fat, sugars, fiber)?
12. Does the use of ``standard drink'' and ``serving size'' on the
same label create confusion? Does any confusion arise if a label
specifies ounces of alcohol in conjunction with serving size and
percent alcohol?
E. Composite Label Approach
The proposed ``Alcohol Facts'' label and the ``Serving Facts''
label have the following informational components in common: (1)
Calorie representation; (2) serving size; (3) number of servings per
container; and (4) alcohol content expressed in fluid ounces. The
components that are unique to only one label type are noted below:
The ``Alcohol Facts'' label also includes the following
information: (1) Alcohol content expressed as a percentage of alcohol
by volume; (2) an icon of an alcohol beverage serving container; (3)
the U.S. Dietary Guidelines advice on moderate drinking; and (4) an
ingredient list.
The ``Serving Facts'' label also includes the following
information: (1) Fat content; (2) carbohydrate content; (3) protein
content; (4) a definition of a ``standard drink'' as well as the number
of standard drinks found in a serving of the alcohol beverage; and (5)
three icons depicting three different alcohol beverage serving
containers, separated by equal (=) signs and each carrying the legend
``0.6 oz.''
TTB is interested in receiving comments on whether a composite
label, which combines the essential information on the examples
discussed, would be appropriate to provide the consumer with
information they want and need to see on alcohol beverage product
labels. TTB is also seeking comments on whether such a composite label
should be mandatory or voluntary.
VI. Submitting Comments
Please submit your comments by the closing date shown above in this
notice. Your comments must include this notice number and your name and
mailing address. Your comments must be legible and written in language
acceptable for public disclosure. We do not acknowledge receipt of
comments, and we consider all comments as originals. You may submit
comments in one of five ways:
Mail: You may send written comments to TTB at the address
listed in the ADDRESSES section.
[[Page 22283]]
Facsimile: You may submit comments by facsimile
transmission to 202-927-8525. Faxed comments must--
(1) Be on 8.5 by 11-inch paper;
(2) Contain a legible, written signature; and
(3) Be no more than five pages long. This limitation assures
electronic access to our equipment. We will not accept faxed comments
that exceed five pages.
E-mail: You may e-mail comments to nprm@ttb.gov. Comments
transmitted by electronic mail must--
(1) Contain your e-mail address;
(2) Reference this notice number on the subject line; and
(3) Be legible when printed on 8.5 by 11-inch paper.
Online form: We provide a comment form with the online
copy of this notice on our Web site at http://www.ttb.gov/alcohol/
rules/index.htm. Select the ``Send comments via e-mail'' link under
this notice number.
Federal e-Rulemaking Portal: To submit comments to us via
the Federal e-rulemaking portal, visit http://www.regulations.gov and
follow the instructions for submitting comments.
You may also write to the Administrator before the comment closing
date to ask for a public hearing. The Administrator reserves the right
to determine, in light of all circumstances, whether to hold a public
hearing.
Confidentiality
All submitted material is part of the public record and subject to
disclosure. Do not enclose any material in your comments that you
consider confidential or inappropriate for public disclosure.
Public Disclosure
You may view copies of this advance notice, the petitions, and any
comments we receive by appointment at the TTB Library at 1310 G Street,
NW., Washington, DC 20220. You may also obtain copies at 20 cents per
8.5 by 11-inch page. Contact our librarian at the above address or
telephone 202-927-2400 to schedule an appointment or to request copies
of comments.
For your convenience, we will post this advance notice and any
comments we receive on this proposal on the TTB Web site. We may omit
voluminous attachments or material that we consider unsuitable for
posting. In all cases, the full comment will be available in the TTB
Library. To access the online copy of this notice, visit http://
www.ttb.gov/alcohol/rules/index.htm. Select the ``View Comments'' link
under this notice number to view the posted comments.
VII. Drafting Information
Lisa M. Gesser and Joanne C. Brady of the Regulations and
Procedures Division drafted this advance notice.
Signed: March 16, 2005.
John J. Manfreda,
Administrator.
Approved: March 31, 2005.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and Tariff Policy).
[FR Doc. 05-8574 Filed 4-28-05; 8:45 am]
BILLING CODE 4810-31-P